Carbetocin txhaj 100 mcg / mlyog ib tug ntev-acting synthetic oxytocin txhaj tshuaj tshwj xeeb uas tsim los rau kev tiv thaiv ntawm postpartum hemorrhage tom qab cesarean seem. Piv nrog cov pa di-sipidin, nws muaj ib nrab lub neej ntev dua, ruaj khov thiab tswj tau lub tsev menyuam, qhov cuam tshuam tsawg kawg ntawm hemodynamics, thiab txhim kho kev nyab xeeb profile. Nrog rau cov koob tshuaj meej thiab kev tswj hwm yooj yim, nws yog qhov tsim nyog rau kev txhaj tshuaj ib leeg lossis txhaj tshuaj intramuscular tom qab yug menyuam hauv plab epidural lossis txha caj qaum rau kev phais.
Khoom Description
Carbetocin \\ Carbetocin AcetateCOA
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| Certificate of Analysis | ||
| Compound npe | Carbetocin \\ Carbetocin Acetate | |
| Qib | Pharmaceutical qib | |
| CAS Nr. | 37025-55-1 | |
| Ntau | 36g | |
| Ntim txheem | PE hnab + Al foil hnab | |
| Chaw tsim tshuaj paus | Shaanxi BLOOM TECH Co., Ltd | |
| Ntau No. | 202601090056 | |
| MFG | Peb 9, 2026 | |
| EXP | Peb 8, 2029 | |
| Qauv |
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| Yam khoom | Enterprise txheem | Kev txheeb xyuas qhov tshwm sim |
| Qhov tshwm sim | Dawb los yog yuav luag dawb hmoov | Ua raws |
| Cov ntsiab lus dej | Tsawg dua lossis sib npaug li 5.0% | 0.54% |
| Poob rau ziab | Tsawg dua lossis sib npaug li 1.0% | 0.42% |
| Hnyav Hlau | Pb Tsawg dua lossis sib npaug li 0.5ppm | N.D. |
| Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Hg Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Cd Tsawg dua lossis sib npaug li 0.5ppm | N.D. | |
| Purity (HPLC) | Ntau dua lossis sib npaug li 99.0% | 99.98% |
| Ib leeg impurity | <0.8% | 0.52% |
| Tag nrho microbial suav | Tsawg dua lossis sib npaug li 750cfu / g | 95 |
| E. Coli | Tsawg dua lossis sib npaug li 2MPN / g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (los ntawm GC) | Tsawg dua lossis sib npaug li 5000ppm | 500ppm ua |
| Cia |
Khaws rau hauv qhov chaw kaw, tsaus, thiab qhuav hauv qab -20 degree |
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| Tshuaj Formula | C45H69N11O12S |
| Exact Mass | 987.48 |
| Molecular Luj | 988.17 |
| m/z | 987.48(100.0%), 988.49(48.7%), 989.49(11.6%), 989.48(4.5%), 988.48(4.1%), 989.49(2.5%), 990.48(2.2%), 989.49(2.0%), 990.49(1.2%) |
| Elemental Analysis | C,54.70; H,7.04; N,15.59; O,19.43; S,3.24 |
Tiv thaiv Uterine Atony tom qab Cesarean Section
1.1 Core Indication
Thawj qhov chaw kho mob qhia txogcarbetocin txhaj 100 mcg / mlyog kev tiv thaiv ntawm uterine atony thiab txo qhov kev pheej hmoo ntawm kev mob ntshav qab zib tom qab yug me nyuam tom qab xaiv txoj kev phais.Cesarean seem yog ib qho kev cuam tshuam obstetric. Raws li Lub Koom Haum Saib Xyuas Kev Noj Qab Haus Huv Ntiaj Teb, nws qhov xwm txheej thoob ntiaj teb yog kwv yees li 15%, nrog kev hloov pauv ntau thoob plaws lub tebchaws thiab cheeb tsam, nce mus txog 52% hauv qee lub tebchaws. Vim yog uterine myometrial trauma thaum lub sij hawm phais, inhibitory cuam tshuam ntawm cov tshuaj loog nyob rau hauv uterine contractility, thiab ib tug neeg sib txawv ntawm niam txiv, qhov tshwm sim ntawm uterine atony tom qab cesarean seem yog ho ntau dua li tom qab yug me nyuam. Uterine atony yog qhov ua rau mob ntshav qab zib tom qab yug me nyuam, uas yog mob hnyav tuaj yeem ua rau niam txiv hemorrhagic shock, tshaj tawm intravascular coagulation, thiab txawm tuag. Yog li ntawd, kev tiv thaiv ntawm uterine atony nyob rau lub sij hawm postoperative yog ib qho tseem ceeb heev.
1.2 Kev Kho Mob Zoo
Piv nrog rau cov pa di-sipidin, cov khoom lag luam qhia qhov zoo sib xws hauv kev tiv thaiv kev ua haujlwm tom qab lub tsev menyuam atony, tshwj xeeb tshaj yog nyob rau lub sijhawm ua haujlwm, yooj yim ntawm kev tswj hwm, thiab kev ruaj ntseg ntawm kev kho mob, raws li cov lus qhia hauv qab no:
Ua ntej, nws muaj lub sijhawm ntev ntawm kev ua haujlwm thiab ua haujlwm zoo dua qub. Pa di-sipidin muaj luv luv ib nrab-lub neej ntawm tsuas yog 4-10 feeb, nrog txwv tsis pub muaj kev cuam tshuam uterine contractile. Nws feem ntau yuav tsum tau txhaj tshuaj tas mus li txhawm rau txhawm rau tswj cov txiaj ntsig zoo rau kev tiv thaiv kab mob ntshav qab zib tom qab yug me nyuam, uas ua rau muaj kev ua haujlwm hauv tsev laus thiab tuaj yeem ua rau ntau dhau los yog tsis txaus uterine contractions vim qhov tsis tsim nyog infusion.
Raws li kev ua yeeb yam ntev di-sipidin analog, carbetocin nthuav tawm kev tshem tawm biphasic tom qab kev tswj hwm cov hlab ntsha, nrog rau qhov nruab nrab qhov kev tshem tawm ib nrab ntawm lub neej txog li 33 feeb; Ib nrab-lub neej yog ntev dua tom qab txhaj tshuaj intramuscular, nrog rau qee qhov kev tshawb fawb pom tias muaj txiaj ntsig zoo rau ob peb teev.
Kev txhaj tshuaj tas mus li yog qhov tsis tsim nyog, muab kev ruaj khov thiab ntev ntawm lub tsev menyuam thiab tsis txhob xav tau kev txhaj tshuaj ntxiv lossis kev txhaj tshuaj tas li yuav tsum tau ua rau cov pa di-sipidin.
Qhov thib ob, nws yooj yim rau kev tswj hwm thiab ua kom yooj yim cov txheej txheem kho mob. Rau kev tiv thaiv kab mob ntshav qab zib tom qab yug me nyuam tom qab phais tas, cov pa di-sipidin yuav tsum tau txhaj tshuaj bolus tam sim ntawd ua raws li kev txhaj tshuaj tas li rau 4-6 teev, nrog rau kev tswj hwm nruj thiab kev noj zaub mov ntau. Los ntawm qhov sib txawv,carbetocin txhaj 100 mcg / mltsuas yog yuav tsum tau txhaj tshuaj maj mam txhaj tshuaj tom qab yug menyuam, ua ntej lossis tom qab yug menyuam, tsis tas yuav tsum tau txhaj tshuaj txuas ntxiv mus. Txoj kev tswj hwm yooj yim ua rau txo qis kev ua haujlwm hauv tsev laus, tshwj xeeb tshaj yog nyob rau hauv chaw ua haujlwm obstetric, thiab txo qis kev pheej hmoo cuam tshuam nrog kev coj ua tsis zoo.
Cov ntaub ntawv
World Health Organization (WHO). LEEJ TWG -PQ tau pom zoo cov ntsiab lus ntawm cov khoom lag luam (RH 095) [R]. Tsis paub.
Instituto de Salud Pública de Chile. FOLLETO DE INFORMACIÓN AL PROFESIONAL DURATOCIN SOLUCIÓN INYECTABLE 100 mcg / 1 mL [R].
Adjunctive Management ntawm Uterine Atonic Hemorrhage
Daim ntawv thov scenarios thiab tus nqi tseem ceeb
Ntxiv nrog rau kev tiv thaiv ntawm post-cesarean uterine atony, cov khoom siv yuav raug siv los ua tus neeg sawv cev ua ke nrog rau lwm cov uterotonics (xws li, cov pa oxytocin, ergometrine, prostaglandins) rau kev kho mob kub ntxhov ntawm refractory postpartum hemorrhage.Postpartum hemorrhage yog qhov ua rau poj niam ntau tshaj 1 lab xyoo dhau los. thiab ua rau 70,000 leej niam tuag. Uterine atonic hemorrhage account rau 70% -80% ntawm cov mob tom qab yug me nyuam. Cov mob no yog qhov ua rau muaj kev phom sij rau lub neej thiab xav tau kev kho mob sai nrog ntau yam uterotonics los txhim kho lub tsev menyuam, tswj cov ntshav, thiab cawm leej niam txoj sia.
Cov ntaub ntawv
World Health Organization (WHO). LEEJ TWG -PQ tau pom zoo cov ntsiab lus ntawm cov khoom lag luam (RH 095) [R].
National Center for Biotechnology Information. Web annex 7 Kev xaiv ntawm uterotonic agents [R]. Tsis paub.
Daim ntawv thov hauv Pharmacological Research Models ntawm Uterine Smooth Muscle
Cov khoom ua hauj lwm pab raws li ib tug tseem ceeb cov cuab yeej tshuaj rau pharmacological kev tshawb fawb ntawm uterine du nqaij. Kev cia siab rau nws qhov ua tau ntev thiab ruaj khov agonistic cuam tshuam ntawm oxytocin receptors, nws yog dav siv hauv vitro, cellular thiab hauv vivo qauv kom meej meej elucidate uterine contraction mechanisms thiab tshuaj cuam tshuam.
Hauv kev sib cais ntawm lub tsev menyuam cov leeg nqaij leeg, qhov kev npaj no feem ntau yog ua haujlwm hauv kev sim da dej hauv nruab nrog cev. Tib neeg los yog tsiaj uterine nqaij strips yog muab tso rau hauv physiological tov, nrog cumulative tswj ntawmcarbetocin txhaj 100 mcg / mlntawm cov concentrations xws li 10⁻¹⁰ mus rau 10⁻⁵ M. Nws cov haujlwm ua haujlwm ntev ruaj khov txhawb cov lus teb cog lus rau ob peb teev, tsis txhob rov ua dua, ua rau nws tsim nyog rau kev tshawb fawb ntawm receptor desensitization, qhia txoj hauv kev thiab kev sib koom ua ke ntawm cov neeg ua haujlwm uterotonic.
Hauv cov qauv ntawm cov nqaij mos ntawm lub tsev menyuam, nws yog siv los kuaj cov kab mob hauv lub cev calcium, myosin lub teeb saw phosphorylation thiab oxytocin receptor (OTR) txoj kev ua kom muaj zog, lees paub nws cov txheej txheem ntawm inducing contraction ntawm Gq-PLC-IP3-Ca²⁺ txoj hauv kev. Nws kuj tseem siv rau hauv kev tshuaj xyuas OTR antagonists thiab ntsuas lub zog ntawm cov tshuaj uterotonic, ua tus qauv cuab yeej hauv kev tshawb fawb thiab kev tsim kho tshuaj.
Nyob rau hauv vivo tsiaj qauv (nas, guinea npua, nees), ib tug thawj coj tso cai saib xyuas ntawm uterine contraction dynamics thiab kev soj ntsuam ntawm postpartum uterine involution thiab hemorrhage tiv thaiv kev ua tau zoo. Nws cov cuab yeej ua haujlwm ntev ua rau txo qhov kev siv tshuaj ntau zaus thiab txhim kho kev sim kev ruaj ntseg.
Cov ntaub ntawv
American Society of Anesthesiologists. Hauv Vitro Kev Sib Piv Cov nyhuv ntawm Carbetocin thiab di-sipidin hauv Pregnant Human Myometrium[J]. Anesthesiology, 2026, 124(2): 378-387.
PubMed. Ex vivo cuam tshuam ntawm carbetocin ntawm equine myometrial leeg thiab kev sib piv nrog di-sipidin[J]. 2012, 76(3): 245-251.
1. API Synthetic txheej txheem
Carbetocin active tshuaj ingredient (API) yog tsuas yog tsim los ntawm solid-phase peptide synthesis, txoj kev tseem ceeb rau cov tshuaj peptide vim nws txoj hauj lwm yooj yim, siab yield, thiab yooj yim ntawm purity tswj. Cov kauj ruam tseem ceeb suav nrog: siv cov amino resin ua cov khoom txhawb nqa, kev tiv thaiv, kev sib txuas ua ke ntawm Fmoc-tiv thaiv cov amino acids, tshem tawm cov cysteine side-chain tiv thaiv pawg ua raws li kev txuas ntawm bromobutyric acid, solid-phase cyclization thiab cleavage kom tawm los crude peptide, thiab qhov kawg purification los ntawm high-reversed LC-RPse-peptide. tau txais high-purity API. Tshwj xeeb coupling thiab cyclization reagents yog siv thaum lub sij hawm synthesis, nrog nruj tswj ntawm cov tshuaj tiv thaiv tej yam kev mob los xyuas kom meej meej amino acid ib theem zuj zus thiab txo impurity tsim.
2. Cov txheej txheem npaj tshuaj
Cov ntawv kho mob siv carbetocin ntau npaum li cas yog txhaj tshuaj, feem ntau ntawm lub zog ntawm 1 mL: 100 ug. Cov txheej txheem tsim khoom nruj me ntsis ua raws li cov txheej txheem aseptic. Cov formulation muaj carbetocin API, excipients, thiab dej rau txhaj. Excipients muaj xws li mannitol, methionine, succinic acid, sodium hydroxide, thiab lwm yam, los kho pH thiab txhim khu kev ruaj ntseg. Thaum lub sij hawm tsim khoom, excipients yog yaj nyob rau hauv dej rau kev txhaj tshuaj, pH yog hloov mus rau 3.0-5.5, purified carbetocin API yog ntxiv thiab yaj, ua raws li pom, sau thiab sealing, thiab terminal sterilization los tsim ib tug ntshiab, tsis muaj xim. Filling precision thiab sterilization tsis yog tswj los tiv thaiv kab mob microbial thiab xyuas kom ua raws li cov qauv kev txhaj tshuaj zoo. Cov khoom lag luam yog tsim los ntawm ntau lub tuam txhab hauv tsev, nrog cov chaw tsim khoom nyob hauv Hangzhou, Zhongshan, Shenzhen, thiab lwm lub nroog.
3. Kev Tswj Xyuas Zoo
Cov qauv kev tswj xyuas nruj nruj siv thoob plaws hauv kev tsim cov carbetocin, npog API, cov khoom tiav, thiab kev khaws cia thiab kev faib tawm.API kuaj suav nrog cov tsos, kev txheeb xyuas, cov tshuaj muaj feem xyuam, tshuaj ntsuam xyuas, cov ntsiab lus dej, cov kuab tshuaj seem, thiab kev txwv microbial. Kev ntsuam xyuas yog ua los ntawm HPLC; cuaj lub npe impurities raug tswj xyuas kom paub meej tias qhov purity tau txais.Tam sim no kev txhaj tshuaj tiav suav nrog cov lus piav qhia, pH, tsis muaj menyuam, cov kab mob endotoxins, tshuaj ntsuam xyuas, thiab lwm yam tshuaj. Kev kuaj tsis muaj menyuam thiab cov kab mob endotoxin yog qhov tseem ceeb rau kev nyab xeeb thiab yuav tsum ua raws li cov cai ntawm pharmacopoeial thiab cov ntawv sau npe.Rau cia, API yuav tsum tau khaws cia lub teeb-tiv thaiv, kaw, thiab khaws cia ntawm -20 degree. Kev txhaj tshuaj tiav yuav tsum tau muab khaws cia rau hauv cov xwm txheej tshwj xeeb. Thaum qhib, API yuav tsum tau siv nyob rau hauv ib lub pob kom tsis txhob muaj kev puas tsuaj zoo vim qhov nqus dej noo.
Cov ntaub ntawv
National Institutes for Food and Drug Control. Cov Lus Qhia rau Kev Siv Tshuaj Hauv Tebchaws: Carbetocin [R].
Phau ntawv Journal of China Pharmaceutical University. Kev txhim kho thiab kev siv tau ntawm ib txoj hauv kev rau cov tshuaj muaj feem xyuam hauv kev txhaj tshuaj carbetocin [J].
World Health Organization (WHO). Carbetocin 100 mcg / mL tov rau kev txhaj tshuaj (Ferring International Center SA), RH095 [R]. Kaum Ib Hlis 2022.
Core Contraindications
Contraindicated thaum cev xeeb tub thiab ua ntej yug menyuam.
Contraindicated nyob rau hauv cov neeg mob hypersensitivity rau carbetocin los yog di-sipidin.
Contraindicated nyob rau hauv cov neeg mob.
Cov ntaub ntawv
Carbetocin Injection Package Insert (Hainan Huanglong Pharmaceutical, 2023 ib tsab); EMA Khoom Qhia: Pabal®; Tuam Tshoj Cov Ntaub Ntawv Kho Mob Query Platform; FDA Cov Lus Qhia rau Carbetocin.
FAQ
Puas yog carbetocin muab IV lossis IM?
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DURATOCIN (carbetocin txhaj) yog ntev - ua yeeb yam octapeptide analogue ntawm oxytocin nrog agonist zog. Nws tuaj yeem tswj tautxhaj tshuajraws li ib koob tshuaj tam sim ntawd tom qab yug me nyuam los ntawm qhov chaw caesarean nyob rau hauv epidural los yog spinal anaesthesia, tiv thaiv uterine atony thiab postpartum haemorrhage.
Vim li cas carbetocin tsis siv hauv PPH?
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Hauv qhov sib piv, cov cua sov- ruaj khov carbetocin tsuas yog qhia rau kev tiv thaiv PPH. Kev siv hluav taws xob tsis tsim nyog- carbetocin ruaj khov, zoo ib yam li lwm cov uterotonics uas twb muaj lawm, tuaj yeem ua rau muaj kev phom sij rau cov poj niam thiab menyuam yaus lub neej. Kev kawm thiab kev saib xyuas, suav nrog cov tshuaj pharmacovigilance, yog qhov tseem ceeb.
Cim npe nrov: Carbetocin txhaj 100 mcg / ml, Tuam Tshoj carbetocin txhaj 100 mcg / ml manufacturers, lwm tus neeg
